The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
Brian Walters, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01765712
First received: January 3, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar tendons as autografts.


Condition Intervention Phase
Post Operative Pain
Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Biological: Platelet Rich Plasma
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Anterior Knee Pain [ Time Frame: 2 weeks, 1, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months


Secondary Outcome Measures:
  • Radiographic assessment of tunnel positioning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.

  • Quantification of healing at the bony and tendinous harvest sites [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist.

  • Post Operative Strength [ Time Frame: 3,6,12,18,24months ] [ Designated as safety issue: No ]
    The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment.

  • Post Operative Range of Motion [ Time Frame: 2 weeks, 1,3,6,12,18,24months ] [ Designated as safety issue: No ]
    The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Patients will be randomized into the treatment arm using a computer generated randomization table (simple randomization). Patients in the control arm of the study will undergo Anterior cruciate ligament reconstruction using Autologous bone patellar tendon bone autograft. At the end of the surgery, their graft donor site will have bone graft chips placed into the bony defect and the wound will be closed using sutures.
Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Other Names:
  • ACL
  • BPTB
Experimental: Platelet Rich Plasma
Patients randomized into the treatment arm of the study will undergo Anterior cruciate ligament reconstruction with Autologous bone patellar tendon bone autografts. At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist. This sample will be spun down into 3-5cc of Platelet Rich Plasma which will be added to the patients bone graft chips and placed into the donor site at the end of the case.
Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Other Names:
  • ACL
  • BPTB
Biological: Platelet Rich Plasma
Other Name: PRP

Detailed Description:

There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation.

The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary ACL Reconstruction
  • Outerbridge </= 2
  • Minimum follow up of two years
  • No ligamentous secondary injury
  • Willingness to participate in study

Exclusion Criteria:

  • Any previous knee injury
  • prior history of anterior knee pain
  • Outerbridge classification 3 or greater
  • Revision ACL
  • Diabetic or smoker
  • Workers compensation patient
  • pregnant or nursing women
  • Any patient with limited English Proficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765712

Locations
United States, New York
NY Orthopedics Recruiting
New York, New York, United States, 10021
Contact: Stephen Nicholas, MD       Snicho55@aol.com   
Contact: Brian L Walters, MD    2124342000 ext 2460    briwalters52@gmail.com   
Principal Investigator: Stephen J Nicholas, MD         
Sub-Investigator: Brian L Walters, MD         
Sub-Investigator: Benjamin Bedford, MD         
Sub-Investigator: Malachy McHugh, PHD         
Sub-Investigator: Sarah Hobart, MD         
Sub-Investigator: Rocco Raccanelli, PA         
Sub-Investigator: Suzanne Sagues, PA         
Sponsors and Collaborators
Brian Walters
Investigators
Principal Investigator: Stephen Nicholas, MD North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: Brian Walters, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01765712     History of Changes
Other Study ID Numbers: 12-160A
Study First Received: January 3, 2013
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
PRP
BPTB
VAS
Anterior Knee Pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014